Medicinal Products

ALFUZOSINE LP ZYDUS 10 mg

Generic drug of Xatral LP
Therapeutic class: Urology nephrology
active ingredients: Alfuzosin
laboratory: Zydus France

Sustained release tablet
Box of 30
All forms

Indication

· Treatment of functional symptoms of benign prostatic hypertrophy.

· Adjunctive bladder catheterization in acute urine retention related to benign prostatic hypertrophy.

Dosage ALFUZOSINE LP ZYDUS 10 mg prolonged release tablet Box of 30

Oral way.

The tablet should be swallowed whole, without crimping, with a glass of water (see Warnings and Precautions ).

adults

The recommended dosage is 1 10 mg tablet daily, to be taken immediately after the evening meal.

Adjuvant bladder catheterization in acute urine retention related to benign prostatic hypertrophy:

The recommended dosage is 1 10 mg tablet daily, to be taken after the meal, from the first day of urethral catheterization.

The treatment is administered for 3 to 4 days including 2 to 3 days during the catheterization and 1 day after the withdrawal of the latter.

Against indications

Hypersensitivity to alfuzosin and / or any of the excipients;

· Orthostatic hypotension ;

· Hepatic insufficiency ;

· Severe renal insufficiency (creatinine clearance <30 ml / min);

· Combination with potent CYP3A4 inhibitors (see section Interactions with other medicinal products and other forms of interaction ).

Side effects Alfuzosine LP Zydus

Adverse reactions are classified by frequency of occurrence using the following rule: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1 / 100), rare (≥ 1/10 000, <1/1000), very rare (<1 / 10, 000), frequency unknown (can not be estimated from available data).

FREQUENCY

ORGAN SYSTEM

Frequent

(≥ 1% - <10%)

Rare

(≥ 0.1% - <1%)

very rare

(<0.01%)

Not determined

Heart conditions

tachycardia,

palpitations

angina pectoris in patients with a history of coronary artery disease

atrial fibrillation

Eye disorders

intraoperative flaccid iris syndrome

General disorders and administration site conditions

Asthenia,

discomfort

edema, chest pain

Gastrointestinal disorders

nausea, abdominal pain

diarrhea,

oral dryness

vomiting

Hepatobiliary disorders

hepatocellular damage,

hepatic cholestasis

Nervous system disorders

dizziness, dizziness, headache

dizziness,

syncope,

drowsiness

Disorders of reproductive organs and breast

priapism

Respiratory, thoracic and mediastinal disorders

nasal congestion

Skin and subcutaneous tissue disorders

rashes, pruritus

urticaria, angioedema

Vascular disorders

orthostatic hypotension, flush

Blood and lymphatic system disorders

neutropenia

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

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